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Compensation: Varies

Number of Visits: 3

88 Participants Needed

Electrocochleography for Hearing Loss
(AB-ECOG Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Chronic otitis media, malformed cochlea, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Electrocochleography for hearing loss?

Electrocochleography (ECoG) has been shown to be helpful in diagnosing and monitoring conditions like Ménière's disease and endolymphatic hydrops, which can affect hearing. It is also used during surgeries for conductive hearing loss to predict hearing improvement, indicating its potential usefulness in managing hearing issues.¹ ² ³ ⁴ ⁵

Is electrocochleography (ECoG) safe for humans?

Electrocochleography (ECoG) has been performed on normal hearing subjects using both extratympanic and transtympanic methods, with no reported safety issues in these studies.¹ ⁶ ⁷ ⁸ ⁹

How does the treatment Electrocochleography differ from other treatments for hearing loss?

Electrocochleography (ECoG) is unique because it measures electrical activity in the cochlea and auditory nerve to assess hearing, using either transtympanic (through the eardrum) or extratympanic (near the eardrum) electrodes. Unlike other treatments that may focus on symptom management, ECoG provides a diagnostic approach to identify and evaluate inner ear disorders, such as Menière's disease, and can aid in early detection of hearing issues.³ ⁶ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The purpose of this study is to see how the inner ear responds to sound delivered to the ear canal during and after your cochlear implant surgery. This information may be helpful in telling us how well a cochlear implant performs after surgery.

Eligibility Criteria

This trial is for individuals aged one year and older who meet the standard requirements for cochlear implant surgery, have a specific level of hearing loss, and no ear abnormalities that would interfere with the implant. It's not suitable for those with auditory neuropathy, chronic ear infections, malformed cochlea, ear tubes in place or past middle ear surgeries.

Inclusion Criteria

You can hear sounds at certain frequencies with a volume of 80 decibels or less.

No additional handicap that would prevent study procedures from being followed

I am at least one year old.

See 2 more

Exclusion Criteria

I have long-term ear infections.

I have a malformed cochlea.

You have ear tubes in your ears.

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-30 days

1 visit (in-person)

Surgery

Cochlear implant surgery with ECochG monitoring during electrode insertion

1 day

1 visit (in-person)

Initial CI Activation

Initial activation of the cochlear implant and audio assessment

3-5 weeks post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person)

Treatment Details

Interventions

Electrocochleography

Trial Overview The study is examining how well the inner ear responds to sounds during and after cochlear implant surgery using a technique called Electrocochleography. This could help understand the effectiveness of cochlear implants post-operation.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2: Audible ECochG Response OnExperimental Treatment1 Intervention

This condition will have the audible ECochG response on and available to the surgeon. In this condition, the surgeon perform a conventional electrode insertion while listening to the running ECochG signal for drop in amplitude (suggesting impending trauma). If no drop is detected, insertion will proceed to the full electrode length according to the standard-of-care. If an ECochG amplitude drop is observed, the surgeon will place this observation in its clinical context and evaluate insertion parameters, (i.e., insertion vector, insertion speed, etc.), customary practice with conventional CI surgery, but here supplemented by the ECochG response. In the case of an ECochG amplitude drop that does not recover, the standard-of-care practice of achieving a full electrode insertion will be followed.

Group II: Arm 1: Audible ECochG Response OffExperimental Treatment1 Intervention

Arm 1: Audible ECochG Response Off This condition is identical to the current standard-of-care for conventional CI surgery used worldwide. The surgeon will perform his or her electrode insertion without ECochG monitoring. Minute manipulations of the electrode are a normal part of conventional electrode insertion; manipulations such as redirecting the insertion vector or slowing down insertion speed will be made, as deemed necessary by the surgeon. A full electrode insertion will be performed, as appropriate. The ECochG responses will be recorded, but the surgeon will be blinded to this information during surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

In a study of 55 patients undergoing cochlear implantation, an amplitude drop of 61% in real-time electrocochleography (ECochG) during electrode insertion was identified as a significant predictor of a 25% loss in hearing one month post-surgery.

The findings suggest that clearly defined ECochG events, particularly those with a steep slope of 0.2 µV/sec, can help guide surgeons to preserve acoustic hearing during cochlear implantation, as larger amplitude drops were associated with worse hearing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a Better Understanding of Electrocochleography: Analysis of Real-Time Recordings.Weder, S., Bester, C., Collins, A., et al.[2021]